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FDA NDA · NDA021937

ATRIPLA

Sponsor: GILEAD SCIENCES

APPLICATION
NDA021937
TYPE
NDA
ORIGINAL APPROVAL
2006-07-12
LATEST ACTION
2019-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ATRIPLA · ReferenceDiscontinued
EFAVIRENZ 600MG, EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-10-29Labeling · Supplement 44 · standard — Label ↗AP
2018-07-25Labeling · Supplement 43 · standard — Label ↗AP
2017-04-07Labeling · Supplement 41 · standard — Label ↗AP
2016-02-11Labeling · Supplement 39 · standard — Label ↗AP
2015-11-20Labeling · Supplement 37 · standard — Label ↗AP
2015-01-23Labeling · Supplement 34 · standard — Letter ↗AP
2015-01-12Manufacturing (CMC) · Supplement 35 · priorityAP
2014-11-26Manufacturing (CMC) · Supplement 33 · priorityAP
2014-07-11Manufacturing (CMC) · Supplement 32 · priorityAP
2013-11-08Manufacturing (CMC) · Supplement 30 · priorityAP
2013-10-23Labeling · Supplement 31 · 901 required — Letter ↗AP
2013-04-17Labeling · Supplement 27 · standard — Label ↗AP
2012-06-14Labeling · Supplement 25 · standard — Letter ↗AP
2011-09-16Labeling · Supplement 23 · unknown — Letter ↗AP
2010-08-06Labeling · Supplement 19 · unknown — Letter ↗AP
2010-01-07Efficacy · Supplement 12 · standard — Label ↗AP
2008-10-18Labeling · Supplement 11 · standard — Letter ↗AP
2008-06-06Efficacy · Supplement 9 · unknown — Label ↗AP
2008-02-28Labeling · Supplement 7 · standard — Label ↗AP
2008-02-15Labeling · Supplement 6 · standard — Label ↗AP
2006-07-12Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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